Single Anastomosis Versus Standard Duodenal Switch

NCT ID: NCT04767490

Last Updated: 2024-08-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-01
• Study Completion Date: 2026-09-01

Brief Summary

Bilio-Pancreatic diversion with Duodenal Switch (BPD-DS) is the most effective bariatric procedure in terms of long-term weight loss and remission rate of Type 2 Diabetes. However, its technical difficulty and increased risk of long-term nutritional deficiencies have been a major hindrance to its diffusion.

Recently, a " simplified " technique of Duodenal-Switch has been proposed by Sanchez-Pernaute et al. This technique involves the creation of a Sleeve Gastrectomy, transection of the first duodenum, and connection of the duodenum to an omega-loop of small bowel instead of a terminal intestinal loop used in standard BPD-DS.

The overall objective of this study is to assess in a prospective randomized blinded trial, the outcomes of this new procedure, using a comprehensive clinical evaluation and follow-up method. This could potentially change the clinical practice and surgical approach in our Institution.

Detailed Description

Bilio-Pancreatic diversion with Duodenal Switch (BPD-DS) is the most effective bariatric procedure in terms of long-term weight loss and remission rate of Type 2 Diabetes. However, its technical difficulty and increased risk of long-term nutritional deficiencies have been a major hindrance to its diffusion. Our team, with more than 4000 BPD-DS performed since the early 1990's, is recognized internationally for its expertise with this specific procedure.

Recently, a " simplified " technique of Duodenal-Switch has been proposed by Sanchez-Pernaute et al. This technique involves the creation of a Sleeve Gastrectomy, transection of the first duodenum, and connection of the duodenum to an omega-loop of small bowel instead of a terminal intestinal loop used in standard BPD-DS.

This new procedure, called Single Anastomosis Duodenal Switch has the potential benefit of decreasing the complexity of the standard BPD-DS by avoiding one of the two intestinal anastomoses usually needed. This could potentially decrease the rate of peri-operative complications and increase access to this type of surgery.

However, the length of the common channel (250cm) is more than doubled compared to standard BPD-DS, which could also change significantly the outcomes of the procedure itself. Indeed, the length of the common channel conditions the absorption of fat and fat-soluble vitamins.

Currently, the scientific literature regarding this procedure is scarce, with only one author who published his 2-years outcomes, in a cohort study of 100 patients. In addition, this report presents major limitations. In example, the length of the omega loop was increased from 200 to 250cm during the course of the study, in order to decrease the rate of protein deficiency and reoperation for malnutrition. This and other limitations make it hard to assess the actual results of the technique.

The overall objective of this study is to assess in a stronger study design (i.e. a prospective randomized single blinded trial), the outcomes of this new procedure, using a comprehensive clinical evaluation and follow-up method. This could potentially change the clinical practice and surgical approach in our Institution.

Conditions

Obesity; Morbid Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

BPD-DS

Biliopancreatic diversion with Duodenal Switch (BPD-DS), with Sleeve gastrectomy, including a 100cm common channel and 150cm stric alimentary limb

Group Type: ACTIVE_COMPARATOR

Standard Duodenal Switch

Intervention Type: PROCEDURE

SADI

Single-Anastomosis Duodeno-Ileal anastomosis (SADI) with Sleeve Gastrectomy, including a 250cm common channel

Group Type: EXPERIMENTAL

Single Anastomosis Duodenal Switch

Intervention Type: PROCEDURE

Interventions

Standard Duodenal Switch

Intervention Type: PROCEDURE

Single Anastomosis Duodenal Switch

Intervention Type: PROCEDURE

Other Intervention Names

BPD-DS; SADI

Eligibility Criteria

Inclusion Criteria

• Age ≥18 years and ≤60 years
• Fulfill criteria for bariatric surgery as coined by National Institutes of Health BMI≥35
• Give written informed consent

Exclusion Criteria

Participants who meet any of the following criteria at the time of the baseline visit are excluded from the study:

• Presence of the following baseline comorbidities:
• Inflammatory bowel disease (IBD),
• Cirrhosis
• History of gastric or duodenal ulcers
• Preoperative hypoalbuminemia (<35 g/L)
• History of severe renal, hepatic, cardiac or pulmonary disease
• Past esophageal, gastric or bariatric surgery
• Type 1 Diabetes
• Pregnancy
• Evidence of psychological problem that may affect the capacity to understand the project and to comply with the medical recommendations
• History of drug use or alcohol abuse in the last 6 months
• History of gastro-intestinal inflammatory diseases

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

OTHER

Sponsor Role: collaborator

Laval University

OTHER

Sponsor Role: lead

Responsible Party

Laurent Biertho

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Laurent Biertho, MD

Role: PRINCIPAL_INVESTIGATOR

Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

Locations

Institut Universitaire de Cardiologie et de Pneumologie de Québec

Québec, Quebec, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Suzy Laroche

Role: CONTACT

suzy_laroche@ssss.gouv.qc.ca

418-656-8711 ext. 3841

Mélanie Nadeau, MSc

Role: CONTACT

melanie.nadeau@criucpq.ulaval.ca

418-656-8711 ext. 3490

Facility Contacts

Suzy Laroche

Role: primary

suzy_laroche@ssss.gouv.qc.ca

418-656-8711 ext. 3841

Other Identifiers

SADI

Identifier Type: -

Identifier Source: org_study_id